Setron medicament oral cavity disintegrating tablet and preparation method thereof

A technology for oral disintegrating tablets and drugs, which is applied to the field of oral disintegrating tablets of setron drugs, can solve the problems of having a gritty feeling, affecting the patient's taste and compliance, slow disintegration of preparations, etc., and achieves no gritty feeling and good taste. , the effect of small gastrointestinal irritation

Inactive Publication Date: 2012-05-16
QUANTUM HI TECH BEIJING RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In China, the preparation technology of orally disintegrating tablets started relatively late. At present, the direct compression method is mostly used to prepare orally disintegrating tablets. Most disintegrants are insoluble in

Method used

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  • Setron medicament oral cavity disintegrating tablet and preparation method thereof
  • Setron medicament oral cavity disintegrating tablet and preparation method thereof
  • Setron medicament oral cavity disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0069] Example 1

[0070] The formulation of the present invention consists of the following components:

[0071] Tropisetron Hydrochloride 5.64g

[0072] Glycine 4.40g

[0073] Pullulan 8.40g

[0074] Acesulfameil 0.50g

[0075] Pineapple flavor 0.50g

[0076] Purified water 180.56g

[0077] 1000 pieces in total

[0078] The specific preparation method is as follows: Mix tropisetron hydrochloride, glycine, pullulan, acesulfame K, and pineapple essence, add a prescription amount of purified water, and mix with an emulsifier to make a uniform solution; After vacuum degassing, it is accurately injected into the mold; after being frozen in liquid nitrogen at -100℃~-110℃ for 6 minutes, it is transferred to a lyophilizer and lyophilized under the conditions of 0.05mbar pressure and -20℃ to 20℃ for 3 hours. The orally disintegrating tablet of tropisetron hydrochloride of the present invention is obtained.

Example Embodiment

[0079] Example 2

[0080] The formulation of the present invention consists of the following components:

[0081] Tropisetron Hydrochloride 2.82g

[0082] Mannitol 4.40g

[0083] Pullulan 8.40g

[0084] Aspartame 1.00g

[0085] Purified water 183.38g

[0086] 1000 pieces in total

[0087] The specific preparation method is as follows: mix tropisetron hydrochloride, mannitol, pullulan, and aspartame uniformly, add a prescribed amount of purified water to it, mix with an emulsifier to make a homogeneous solution; vacuum the solution After degassing, it is accurately injected into the mold; after freezing in liquid nitrogen at -120℃~-130℃ for 3min, incubating at -10℃ for 12h, transfer to the freeze dryer, under the conditions of 0.02mbar pressure and -20℃ to 20℃ It is freeze-dried for 3.5 hours to obtain the tropisetron hydrochloride orally disintegrating tablet of the present invention.

Example Embodiment

[0088] Example 3

[0089] The formulation of the present invention consists of the following components:

[0090] Tropisetron Hydrochloride 2.82g

[0091] Glycine 2.00g

[0092] Pullulan 2.00g

[0093] Dextran-70 1.00g

[0094] Purified water 192.18g

[0095] 1000 pieces in total

[0096] The specific preparation method is as follows: Mix tropisetron hydrochloride, glycine, pullulan, and dextran-70 uniformly, add a prescribed amount of purified water to it, mix with an emulsifier to make it a homogeneous solution; degas the solution in vacuum Then, it is accurately injected into the mold; after freezing with liquid nitrogen at -110℃~-120℃ for 4min, incubating at -40℃ for 2h, transfer to the freeze dryer, and freeze under the conditions of 0.1mbar pressure and -20℃ to 20℃ After drying for 4 hours, the tropisetron hydrochloride orally disintegrating tablet of the present invention is obtained.

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Abstract

The invention relates to a setron medicament oral cavity disintegrating tablet and a prescription and process for preparing the setron medicament oral cavity disintegrating tablet by adopting a freeze-drying method. The setron medicament oral cavity disintegrating tablet provided by the invention is prepared from a main medicament and pharmaceutical adjuvants. When the setron medicament oral cavity disintegrating tablet is administered, water is not need, and the setron medicament oral cavity disintegrating tablet can be rapidly disintegrated after entering the oral cavity; the setron medicament oral cavity disintegrating tablet is suitable for being taken by the patients with dysphagia such as the elder, children and the like; and meanwhile, the setron medicament oral cavity disintegrating tablet is taken without need of water, thus the symptoms of nausea and vomiting are not aggravated, has better compliance and treatment effect to nausea and vomiting caused by chemotherapy, radiotherapy or operation, and can obviously lower the side effects of setron medicaments. In addition, the invention also relates to a preparation method of the setron medicament oral cavity disintegrating tablet.

Description

Technical field: [0001] The invention relates to an orally disintegrating tablet of a setron-like drug and a preparation method thereof, in particular to an orally disintegrating tablet of a setron-like drug prepared by a freeze-drying method. Background technique: [0002] Chemotherapy and radiotherapy are important and effective means of tumor treatment, but 20% to 30% of patients will experience nausea and vomiting while receiving chemotherapy and radiotherapy, and patients often reduce or even stop treatment due to intolerance. The highly selective 5-HT3 receptor antagonist developed in the 1990s is used for antiemetic during tumor chemotherapy and radiotherapy. breakthrough progress. [0003] Setron drugs are potent and highly selective peripheral and central nervous system 5-HT3 receptor antagonists, which are highly selective for peripheral and central nervous system 5-HT3 receptors, and their anti-emetic mechanism is highly selective Block the abdominal vagus nerve...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K45/08A61J3/00A61P25/00A61P1/08
Inventor 王丛威王洪飞王丽滨王彦峰周立运
Owner QUANTUM HI TECH BEIJING RES INST
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